The author is a Forbes contributor. The opinions expressed are those of the writer.

Loading ...

Loading ...

This story appears in the {{article.article.magazine.pretty_date}} issue of {{article.article.magazine.pubName}}. Subscribe

What is the appropriate venue for deciding the veracity of a contested study published in a medical journal - the court of scientific opinion or a court of law? In a decision that should intrigue free speech advocates, researchers and, of course, pharmaceutical advertisers, a federal appeals court has ruled that scientific debate should be resolved among scientists.

At issue was a lawsuit filed by a small drugmaker called ONY, which claimed a rival had engaged in false advertising through its role in publishing a paper in a medical journal that allegedly 'cherry picked' and 'manipulated' clinical trial data in such a way that its product was unfairly disparaged. Just the same, the appeals court ruled that the conclusions of a study are protected by the First Amendment.

Here is the background: Two years ago, a study in the Journal of Perinatology concluded that Curasurf, a drug used to treat neonatal Respiratory Distress Syndrome and sold by and its parent, Chiesi Farmaceutici, significantly reduced the likelihood of death when compared with Infasurf, which is sold by ONY (here is the study).

However, ONY charged the study was methodologically unsound because the authors failed to include all of the pertinent data. For instance, ONY claimed the study reported a lower mortality for infants treated with Curosurf, but omitted data indicating these babies also had shorter hospital stays, which ONY maintained is a critical distinction that would have accounted for an outcome favorable to its rival.

“They purposely fudged the data and engaged in selective distortion to produce bogus conclusions to promote their product,” ONY president Ted Egan said in a statement at the time the lawsuit was filed. “A premature baby with a reported short hospital stay either died early or was healthier because (it was) close to full-term. The only way the Curosurf infants could have both a lower mortality and a shorter hospital stay is if those infants were more mature and less ill than Infasurf-treated babies.”

Moreover, ONY charged that the circumstances surrounding the publication of the journal article were unusual. The parent company sponsored the study, three of the four authors served as Chieisi consultants and the fourth worked for Premier Research Services, which was a Chiesi contractor hired to build a database for the study. Also, two of the four authors served on the journal editorial board.

However, the US Court of Appeals for the Second Circuit rejected the notion that the scenario amounted to false advertising. Why? The court reasoned that the issue comes down to opinion versus fact – generally, statements of pure opinion are protected by the First Amendment, but the line between fact and opinion is not always clear, the court wrote. And this is such a case.

The argument made by ONY was that the scientific claims made in the study purported to be statements of fact that are falsifiable, and can be defamatory or represent false advertising if these were known to be false at the time of publication. And the drugmaker appealed a lower court ruling that decided the findings of the study were “debatable hypotheses rather than assertions of unassailable fact.”

In ruling against ONY, the appeals court noted that, while conclusions in a journal article may be presented as fact, such findings are often subject to further interpretation and revision as part of the ongoing process of research and scientific rigor. As a result, a court is “ill-equipped” to assume the role of referee when controversy erupts.

“It is clear to us that, while statements about contested and contestable scientific hypotheses constitute assertions that about the world that are in principle matters of verifiable ‘fact,’ for purposes of the First Amendment and the laws relating to fair competition and defamation, they are more closely akin to matters of opinion, and are so understood by the relevant scientific communities,” the court wrote.

And in this case, the court continued, ONY did not assert that there was fraudulent data, only a contention that a fuller set of data was not published in the study. As a result, the validity of the methods used to prepare the study can later be questioned by the scientific community as part of an ongoing analysis or debate.

“We therefore conclude that, to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is a legitimate ongoing scientific disagreement, those statements are not grounds for a claim of false advertising,” the court ruled (here is the ruling).

So what might this mean for drugmakers as they go about promoting their medicines? For one, false advertising claims can still be made. If a drugmaker misstates a conclusion or omits material data from promotional materials, a court could rule that false advertising took place, notes Paul Llewellyn, an attorney at KayeScholer, who is co-head of the trademark, copyright and false advertising group.

“The court is saying that it’s not going to second guess and get behind the scientific process and look at other variables,” he says. “I don’t think it provides a precise road map for what’s okay (for a pharmaceutical manufacturer) to do in the future, but I do think it does provide some useful background for future litigation.”